ACTIVE_NOT_RECRUITING

A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.

Official Title

A Phase 1, Open-Label Study to Evaluate the Safety and Tolerability of a Combination Autologous CD19 CAR T Cell Therapy (SYNCAR-001 + STK-009) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease

Quick Facts

Study Start:2025-04-29
Study Completion:2041-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06544330

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. History of or active central nervous system manifestations of autoimmune disease.
  2. 2. Prior treatment with anti-CD19 adoptive T cell therapy, or any prior gene therapy product (e.g., CAR T cell therapy).

Contacts and Locations

Study Locations (Sites)

HonorHealth Research Institute
Scottsdale, Arizona, 85258
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Feinstein Institutes for Medical Research
Manhasset, New York, 11030
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Synthekine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-29
Study Completion Date2041-04

Study Record Updates

Study Start Date2025-04-29
Study Completion Date2041-04

Terms related to this study

Keywords Provided by Researchers

  • CAR T
  • CD19-CAR T
  • Chimeric antigen receptor
  • IL-2

Additional Relevant MeSH Terms

  • Systemic Lupus Erythematosus
  • Lupus Nephritis
  • Systemic Sclerosis